BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 1881849 · Received October 8, 2010

    Report

    Report Number
    1036844-2010-00313
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRAL VENOUS CATHETER (CVC) WAS PLACED IN A FEMALE PT IN AUGUST (EXACT DATE UNK). THE NURSE MANAGER REPORTED THAT THE LUER LOCK CONNECTOR OF THE DISTAL LUMEN (BROWN HUB) BECAME SEPARATED FROM THE CATHETER EXTENSION LINE. IT WAS NOTICED WHEN THE PT WAS RECEIVING A TOTAL PARENTERAL NUTRITION (TPN) INFUSION AND THE INFUSATE WAS DRIPPING ALL OVER THE PT. THE NURSE MANAGER STATED IT LOOKED LIKE THE HUB JUST CAME OFF. THERE WAS NO SIGN OF TEARING OR CUTTING AND THERE WAS NO TUBING LEFT IN THE HUB UPON INSPECTION. AS A RESULT, THE CATHETER WAS DISCONTINUED AND A PERIPHERAL IV WAS PLACED. IT IS UNK IF THERAPY WAS DELAYED. THERE WAS NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR